NCT01367652

Brief Summary

The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

June 3, 2011

Last Update Submit

January 19, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    31 days

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

2.5 mg tablet

Drug: Letrozole

Femara

ACTIVE COMPARATOR

2.5 mg tablet

Drug: Letrozole

Interventions

LetrozoleDRUG

2.5 mg tablet

Also known as: Femara
Femara

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to letrozole or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alan Copa, PharmD

    PRACS Institute, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)